t r i m p h

Temperature Responsive

Injectable

Modifiable

Peptide Hydrogel

WHO WE ARE

Trimph is an Australian biomedical company that has developed an injectable class of scaffolds that is able to regenerate bone, cartilage and connective tissues. Trimph’s scaffolds are fully synthetic and resorbable to the body. Trimph has a robust Intellectual Property portfolio including a granted patent in the USA and Europe as well as multiple international patent applications.

The technology was co-invented by Dr Ali Fathi during his PhD at the University of Sydney. Ali and Terence founded Trimph in August 2015 and since then, established company’s ISO13485-2016 certified production facility, completed the first in human trial and secured private and public funds. Trimph has manufacturing, regulatory, clinical and technical expertise to launch minimally invasive therapeutic alternatives to improve patient outcomes.

the technology

Injectable

Trimph’s device is an injectable scaffold that can be administered to different injured tissues without the need for invasive surgery.

Temperature Responsive

At body temperature, Trimph’s device forms an adhesive gel to provide a physical scaffold that mimics the matrix formed during the early stages of healing.

Regenerative

Resorbable

Over time, host cells repair the damaged tissue while Trimph’s scaffold resorbs to the body, leaving healthy tissue.

Production Facility

Trimph has established its own cleanroom production facility that is fully equipped to manufacture sterile medical devices. The infrastructure and the associated quality management system are ISO13485:2016 certified. Trimph’s in-house production facility is of a great importance for quality control, protection of technology know-hows, product development and production scalability. In addition, the company’s certified production capability facilitates efficient clinical development.

Clinical Use

Trimph completed its first in human trial in Perth, Australia. The pilot trial involved the use of Trimph’s scaffold for socket preservation post tooth extraction in 10 patients. In all patients, Trimph’s device was successfully administered; there was no need for use of membrane or micro-suturing at the extraction site. This allows the principle investigator (A/Prof Calder) to save time in the theatre. In follow-up visits, wound closure was noted at seven days post-extraction and there was no sign of infection or inflammation in any patients. Three months post use of TrimphDent, tissues biopsies were collected from the site for histochemical analyses; the results showed that the product was fully resorbed and there was no sign pathological abnormality at the site. In addition, active bone remodelling was also noted at the site.

100%

Useability

Easily injectable, instant gelation,and no device malfunctions

100%

Safety

No infection, inflammationor pain reported

100%

Wound Healing

Wound closure notedat 7 days post-extraction

90%

Bone Activity

Active bone remodellingin all collected tissue samples

*Change in treatment plan due to personal circumstances.

Technology

Covalently bonded smart polymer and peptide

In molecular level, Trimph is a water based solution of a propietry patent smart polymer and peptide that are covalently bonded. Upon the injection to the body, the product forms an elastic scaffold (hydrogel). To address different clinical needs, mechanical properties, adhesivity and the resorption rate of Trimph can be tuned.

In molecular level, Trimph is a water based solution of a propietry patent smart polymer and peptide that are covalently bonded. Upon the injection to the body, the product forms an elastic scaffold (hydrogel). To address different clinical needs, mechanical properties, adhesivity and the resorption rate of Trimph can be tuned.

Smart polymer

The smart polymer is poly(N-isopropylacrylamide )-co-(polylactide/2-hydroxy methacrylate)- co -(oligo (ethylene glycol), denoted as PNPHO. Trimph’s smart polymer consists of four main building blocks, called monomers. The chemical composition of PNPHO and the role of each monomer is as follows;

N-acryloxysuccinimide, to be able to bond with peptides to impart the required structural stability to Trimphd

Polylactide/2-hydroxy methacrylate to be able to adjust the mechanical properties of Trimph

Oligo (ethylene glycol) to make PNPHO water soluble.

The smart polymer is poly(N-isopropylacrylamide )-co-(polylactide/2-hydroxy methacrylate)- co -(oligo (ethylene glycol), denoted as PNPHO. Trimph’s smart polymer consists of four main building blocks, called monomers. The chemical composition of PNPHO and the role of each monomer is as follows;

N-acryloxysuccinimide, to be able to bond with peptides to impart the required structural stability to Trimphd

Polylactide/2-hydroxy methacrylate to be able to adjust the mechanical properties of Trimph

Oligo (ethylene glycol) to make PNPHO water soluble.

Peptide

Amine groups of peptides can bond covalently to succinimide ester arms of PNPHO smart polymer. The resorption rate of the final product can be tuned by the degree of crosslinking between PNPHO and peptide. This allows the formulation of Trimph hydrogels with varying physical properties for different clinical applications.

Amine groups of peptides can bond covalently to succinimide ester arms of PNPHO smart polymer. The resorption rate of the final product can be tuned by the degree of crosslinking between PNPHO and peptide. This allows the formulation of Trimph hydrogels with

MILESTONES

Trimph has a robust Intellectual Property portfolio including a granted patent in the USA and Europe as well as multiple international patent applications. The granted patent covers the proprietary smart polymer. Further patent fillings protect specific formulations of the polymer and relevant clinical applications.

Trimph’s production facility in Alexandria, Sydney is capable of producing 500 sterile devices per week. Quality control and quality assurance of the manufacturing process as well as tractability and distribution of products are governed certified quality management.

Trimph has completed cytotoxicity and biocompatibility study in accordance with ISO10993 requirements. Trimph’s devices are well tolerated in the body and biocompatible. In addition, numerous animal studies confirmed the ability of the product for the regeneration of different tissues.

Trimph products are produced locally under the close supervision of Trimph’s technical team at its own production facility. The associated Quality Management System is ISO13485:2016 certified by BSI. The ISO certification covers the production of all Trimph based, sterile and injectable medical devices.

With the aid of NSW Health and Accelerating Commercialisation funding, Trimph completed its First-in-Human Trial. Trimph’s pilot trial was conducted in Perth under ICH/GCP and ISO 14155 requirements. The product was well-tolerated in all patients as there was no report of discomfort, pain, infection or inflammation at the site. Wound closure was also noted within 7 days post tooth extraction. Preliminary results also showed active bone remodelling at the socket site.

The Team

Dr Ali Fathi

Chief Executive Officer | Co-founder

Ali was instrumental in transitioning Trimph from a University research project to a tangible corporate entity. Ali developed Trimph’s technology during his PhD at the University of Sydney. Ali’s biochemical and entrepreneurial aptitude provide both the technological and commercial expertise upon which Trimph is based.

Terence Abrams

Chief Operating Officer | Co-founder

Terence’s Chemical Engineering background and his pervious experiences as CTO and Production Manager of two biomedical start-up companies provide the expertise necessary to manage Trimph’s production and further product development. Terence was instrumental in securing the capital investments, necessary to co-found Trimph. Terence will oversee all future business and product development of the company.

Dean Miller

Director

Dean is an entrepreneur, specialising in developing and monetizing start-up businesses. Dean’s experience in marketing, corporate networking and access to funding is crucial for further development of Trimph. Dean is a pioneer and has an uncanny ability to identify emerging markets and business ideas.

Ian Abrams

Director

Ian is a compounding pharmacist and previous Managing Director with almost 30 years of experience in pharmaceutical and medical-related industries. Ian brings a wealth of corporate expertise in his ability to manage large companies in the medical field. Ian is personable and well versed in the medical industry; these qualities are essential in his role of business development and to establish networks of clinicians.

Dr Dax Calder

Clinical Advisor

Dr Dax Calder is a member of Trimph’s clinical advisory team. Dax is a specialist periodontist with teaching positions at the University of Sydney and University of Western Australia. Dr Calder has spent more than 20 years of his professional career trying to simplify and improve techniques relating to dental implant surgeries and bone augmentation procedures.

Rob McInnes

Transactions Advisor

Rob McInnes holds the position of Board Secretary, Licensing Executives Society International. For nearly a decade, Rob has been ranked as Australia’s highest recommended patent and technology licensing lawyer. He specializes in the commercialisation of novel technologies, and in the intellectual property-related aspects of major corporate transactions. He is an expert in the structuring and negotiation of contracts for the development and commercialisation of innovations.

Dr Teresa Nicoletti

Regulatory Advisor

Dr Teresa Nicoletti is both a lawyer and scientist with more than 20 years’ experience in the pharmaceutical, biotechnology and medical device industries. Teresa’s expertise includes regulatory and reimbursement issues; patent protection and infringement; product liability; corporate governance and compliance; clinical research; promotion and advertising; product safety and recalls; and competition and consumer law.

Marjan Mikel

Commercial Advisor

Marjan brings a wealth of international experience (28 years) from the medical and pharmaceutical industries. Marjan has been involved in bringing new medical devices and pharmaceuticals to the market with experience in Europe, USA and Asia Pac/Japan. Marjan’s access to and knowledge of the industry is an invaluable asset in the company’s progression.

Dr Peter Tsakaris

Clinical Advisor

Peter (DDS, MSc Dent, FCD OMFS, MDent OMFS) is a practising maxillofacial surgeon and Trimph’s Clinical Advisor. Dr Tsakiris provides clinical input into the development of Trimph’s product range as well as oversee planned human preclinical testing. Peter brings national and international key opinion leaders in his area of expertise, necessary for Clinical Trials.

CONTACT US

For more information or product for research purposes, please contact us.

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